Clause 7 - Verification

ANSI/ISA-84.00.01-2004-1 requires the development of a verification plan to define the verification activities that are to take place. There was no specific verification clause in ANSI/ISA-84.01-1996 standard. However, most owners/operators include a number of verification steps during project execution for project and quality management purposes. 

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As described in ANSI/ISA-84.00.01-2004-1, Clause 3.2.92, verification is the activity of demonstrating for each phase of the SIS lifecycle that the results satisfy the defined objectives and requirements for that phase of the lifecycle. It is important that verification planning take place early in a project. As described in ANSI/ISA-84.00.01-2004-1, Clause 7, verification activities are the quality control checks for the project. The amount of verification required for a project is dependent on the scope of work and the number of parties involved in implementing the SIS. The only required verification activity is the verification of the SIL of the SIF in accordance with ANSI/ISA-84.00.01-2004-1, Clause 11.9. 

Performing product design verification and validation (clauses 4.4.7 and 4.4.8.1) Reviewing product design changes (clause 4.4.9.1)... 

The techniques of design verification identified in clause 4.4.7 can be used to verify that the design output meets the design input requirements. However, design verification is often an iterative process. As features are determined, their compliance with the require-... 

Within the clause on verification in ISO/TS 16949 there are no constraints on the standards to be applied to development models used for verifying the design. There are, however, requirements for prototypes under Design validation but they only apply when required by the customer. 

Clause 4.6.2.1 requires that you define the extent of subcontractor control but neither this clause nor clause 4.6.4.1 requires you to plan, execute, or record any verification at... 

The requirements pertain to your customer verifying product purchased by you either at your supplier or on your premises. Verification of purchased product is normally carried out by the supplier before or after receipt as part of the purchasing process but may also be carried out by the customer. However, due to the standard locating most of the inspection and test requirements in clause 4.10, the receipt inspection requirements are displaced. 

The verification carried out, however, has to be in accordance with some plan. The standard requires firstly that you verify conformance and secondly that you should do it in accordance with some plan or other. Your plans, therefore, need to prescribe the acceptance criteria for carrying out such verification. If the standard required that you verify conformance in accordance with the quality plan, as it does in clause 4.10.3, it would give you the option of not specifying any measures at all in your quality plan for verifying conformance, but this has been covered by the requirements of 4.10.1 as already explained. 

Management review records (clause 4.1.3) Process verification records (clause 4.2.4.9.4) Contract review records (clause 4.3.4)... 

Design verification measures (clause 4.4.7) Design validation records (clause 4.4.8.2)... 

Verification records for test hardware and test software (clause 4.11.1.1) Calibration records (clauses 4.11.2 and 4.11.3)... 

The standards for intrinsic safety - i EN 50020 and IEC 60079-11, define the scope of type verifications and tests as well as routine verifications and tests (in clauses 10 and 11). Among the type tests ... 

Test reports are technical records on the conformity assessment of a product according to specific standards. Test reports are concise accounts, including clause-by-clause details on the results of the product safety/EMC assessment, standards rationale, test data, construction, and critical components. Test reports are an essential tool for conformity assessment. Test reports contain the technical results of the conformity assessment and need not contain confidential design information. Test reports may be requested by customers, testing/certification bodies, or enforcement authorities for review and verification purposes. 

The required combination is identified in the particular clause for serviceability verification (see Chapter 4). 

Management of functional safety (clause 5) Determination of function and integrity (clause 8) Verification and validation (clause 7, 12.3, 12.7, clauses 13 and 15)... 

The objective of this clause is to demonstrate by review, analysis and/or testing that the required outputs satisfy the defined requirements for the appropriate phases (Figure 8) of the safety life cycle identified by the verification planning. 

Verification planning shall be carried out for each phase of the application software life cycle in accordance with Clause 7. 

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